Table of Content


Chapter 1 Introduction
Study Goals and Objectives
Scope of Report
Information Sources
Analyst’s Credentials
Related BCC Research Reports
Chapter 2 Governing Authority and Classification
Governing Regulatory Authority
Medical Device Definition and Classification
Chapter 3 Regulations
Code of Federal Regulations (CFR)
eCFR
Premarket Notification 510(k) Clearance to Market

510 (k) Exempt Devices
PMA (Pre-Market Approval)
Good Manufacturing Compliance (GMP) Compliance
Establishment Registration
Device Registration and Listing
Labelling Requirement
Advertising
Medical Device Reporting (MDR)
Local Agent Requirements
Responsibilities of the US agent
Medical Device User Fee



List of Figures


Figure 1 : Process for Marketing the Medical Device in the US Market

 

List of Tables


Table 1 : Class I and Class II Exempt Devices
Table 2 : Medical Device User Fee Amendments (MDUFA)-2020